Method for providing nutrition to elderly patients

ABSTRACT

The present invention provides a method for providing nutrition to elderly patients. Pursuant to the present invention, the enteral composition includes a protein source, a lipid source, and a carbohydrate source. Preferably, the protein source includes at least 18% of the total calories. In an embodiment, the carbohydrate source includes a source of dietary fiber including a balance of soluble to insoluble fiber ratio of approximately 1:3. Still further, the composition of the present invention also includes increased levels of certain vitamins and minerals.

This is a continuation of application Ser. No. 08/372,558, filed Jan.13, 1995 and now U.S. Pat. No. 5,589,468.

BACKGROUND OF THE INVENTION

The present invention relates generally to the treatment and nutritionalsupport of patients. More specifically, the present invention relates toproviding nutrition to elderly patients.

Americans greater than 65 years old were, at the turn of the century, 4%of the population; currently, they are greater than 12% of thepopulation. Though only 12% of our population, the elderly account forgreater than 40% of our acute hospital bed days, buy greater than 30% ofall prescription drugs and spend 30% of our greater than 600 billiondollar health budget. Still further, it is estimated that in 2030,greater than 70 million Americans (1:5) will be over the age of 65, andthe "over 85's" are expected to experience the highest percentageincrease of all. The Merck Manual, 16th Edition, p. 2540.

As the average age of the population increases, obtaining a betterunderstanding of the unique aspects of aging in relation to nutritionalneeds and treatment is imperative. Many physiologic functions declineprogressively throughout adult life and have an impact on nutrition. Forinstance, a reduction in the number of functioning cells and theresultant slowing of metabolic processes results in a decrease incaloric requirements among the elderly. Also, the reduction in physicalactivity that generally accompanies aging further decreases energyrequirements.

Merely decreasing the total caloric intake of an elderly patient mayadversely affect the required nutrition of the patient. When the totalcaloric intake is reduced, the remaining food intake must carefullyinsure a properly balanced intake of proteins, vitamins and minerals. Toreduce caloric intake in the elderly, consumption of "empty" calories(i.e. fats) must be reduced and consumption of nutrient-dense foods(i.e. carbohydrates and proteins) must be increased.

While the nutritional needs of the mature adult patient differ fromadult patients, in the health care settings, standard nutritionalformulas are the primary form of elemental nutrition currently beingused for the elderly. Naturally, standard formulas do not take intoeffect the known nutritional needs of the elderly patients. Thesestandard nutritional products must be supplemented with keymicronutrients to compensate for common deficiencies and metabolicchanges of the elderly patient. Moreover, since the elderly have adiminished capacity to manage a fluid load, standard formulas must bemodified to produce a calorically dense formulation that will provideincreased energy and nutrition with a minimum amount of fluid.

Therefore, a need exists for a nutritional formula designed to meet thenutritional needs of elderly patients.

SUMMARY OF THE INVENTION

The present invention provides a nutritional composition designed forelderly patients. More specifically, the present invention provides amethod for providing nutrition to an elderly patient.

In an embodiment, the method of the present invention includes the stepsof administering to the patient an effective amount of a compositionincluding a protein source making up at least 18% of the caloriedistribution of the composition; a carbohydrate source; and a lipidsource including a mixture of medium and long chain triglycerides.

In an embodiment, the composition provides at least 100% of the USRDA ofvitamins and minerals.

In the embodiment, the composition includes a source of dietary fiberhaving a soluble fiber to insoluble fiber ratio of approximately 4:1 to1:4. Preferably, the soluble fiber constitutes approximately 30% of thedietary fiber source.

In an embodiment, the composition includes increased levels of keyvitamins and minerals found to be deficient in the institutionalizedelderly. Specifically, the composition includes increased levels ofvitamin C, zinc, vitamin D, vitamin E, vitamin A, folic acid, vitaminB₆, vitamin B₁₂, thiamine, riboflavin, calcium and selenium.

In an embodiment, the composition further includes an omega-6 to omega-3fatty acid ratio of approximately 4:1 to 10:1.

In another embodiment, the method of the present invention includes thestep of administering to the patient an effective amount of acomposition including a protein source, a carbohydrate source includinga source of dietary fiber having a soluble fiber to insoluble fiberratio of about 4:1 to 1:4 and a lipid source including a mixture ofmedium and long chain triglycerides.

Still further, in another embodiment, the method of the presentinvention includes the step of administering to the patient atherapeutically effective amount of the composition comprising a proteinsource, a carbohydrate source, a lipid source including a mixture ofmedium and long chain triglycerides, and a vitamin and mineral sourceincluding key vitamin and minerals found to be deficient in theinstitutionalized elderly. Specifically, the composition includes thefollowing vitamins and minerals and their respective amounts: vitamin Ccontaining from about 120 to 300 mg/L; zinc containing from about 15 to30 mg/L; vitamin D containing from about 400 to 800 mg/L; vitamin Econtaining from about 60 to 180 mg/L; vitamin A containing from about3000 to 6000 IU/L; folic acid containing from about 400 to 1600 μg/L;vitamin B₆ containing from about 2 to 8 mg/L; vitamin B₁₂ containingfrom about 6 to 8 μg/L; thiamine containing from about 1.5 to 3 mg/L;riboflavin containing from about 1.7 to 3.5 mg/L; calcium containingfrom about 800 to 1600 mg/L and selenium containing from about 50 to 150μg/L.

An advantage of the present invention is that it provides a nutritionalcomposition that is ready-to-use, nutritionally complete, and containsproteins, lipids, carbohydrates and vitamins and minerals in proportionsappropriate for elderly patients.

Moreover, an advantage of the present invention is that it provides anutritional diet for tube and oral use designed for optimal toleranceand absorption in elderly patients.

Another advantage of the present invention is that it provides acomposition containing higher levels of key micronutrients to compensatefor common deficiencies and metabolic changes in elderly when comparedwith standard formulas.

Furthermore, an advantage of the present invention is that it eliminatesthe need for vitamin supplementation and meets regulatory requirementsof the elderly.

Yet another advantage of the present invention is that it includes anideal fiber balance to promote good bowel function in aging patients.More specifically, the ideal fiber level of the present invention avoidsconstipation and prevents impaction.

Still another advantage of the present invention is that it provides acomposition with increased protein levels to account for the increasedneeds often found in the institutionalized elderly. The composition ofthe present invention addresses the increased repletion requirements forprotein-energy malnutrition in the older patient.

Moreover, an advantage of the present invention is that it provides acalorically dense formulation that allows for increased energy andnutrition with a minimal amount of fluid. Uniquely, the composition ofthe present invention meets or exceeds U.S. RDA for vitamin and mineralsin one liter. As a result, the composition of the present invention isappropriate for fluid-restricted patients and is designed to accommodateslower gastric emptying, which may be seen in the elderly.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the detailed description of thepresently preferred embodiments.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENT

Nutritional support of elderly requires prevention, recognition andtreatment of nutritional depletion that may occur with aging andillness. The methods of the present invention are designed specificallyto provide nutritional support to elderly patients. In this regard, thecomposition of the present invention is designed to meet the energyneeds of an elderly patient in a reduced volume.

The protein source of the present invention provides approximately 16%to 25% of the total calories of the composition. In an embodiment, theprotein source is caseinate. In an embodiment, the protein sourcecomprises at least 18% of the total calories of the composition.Relative to calorie needs, the elderly patient needs an increased amountof protein. Therefore, the composition of the present invention includesslightly higher protein levels than standard formulas to account forincreased needs often found in the institutionalized elderly.

The inventors believe that the increased protein in the composition ofthe present invention helps correct the protein-energy malnutritionoften found in elderly patients. The higher intake of protein maycorrect immunologic deficiencies associated with protein depletion.Moreover, the higher intake may prevent skin breakdown, which is highlycorrelated with protein depletion. Still further, the higher proteinlevel promotes more rapid restoration of body protein stores thatdecrease with age.

Carbohydrates provide approximately 48% to 55% of the caloric content ofthe composition. In an embodiment, a carbohydrate source isapproximately 52% of the caloric content of the composition.Carbohydrates are an important energy source for the elderly patient asthey are readily absorbed and utilized. A number of carbohydrates can beused including maltodextrin or sucrose.

In addition to simple sugars, the carbohydrate source, in an embodiment,includes a source of dietary fiber. Numerous types of dietary fiber areavailable. Dietary fiber passes through the small intestine undigestedby enzymes and represents a kind of natural and necessary laxative.Suitable sources of dietary fiber, among others, include soy, oat or gumarabic.

The total fiber contained in the composition is approximately 8 to 15g/L. While fiber is necessary for the elderly population sinceconstipation is a chronic problem, the composition of the presentinvention contains less total fiber than other products to alleviateproblems associated with impaction and the increased water requirementsassociated with high amounts of fiber. Some older adults may not easilytolerate large amounts of fiber without adaption. In fact, patients onnarcotics or with ultramotility may be at risk for bowel obstruction,especially with the administration of excess fibers. Moreover, highfiber intake may bind calcium, reducing absorption--particularly giventhe high incidence of atrophic gastritis in the elderly. In a preferredembodiment, the composition includes approximately 10 g/L of totalfiber.

In an embodiment, the dietary fiber is a mixture of soluble andinsoluble fiber. The inventors believe that a mixture of soluble andinsoluble fibers may prevent or reduce constipation and lower serumcholesterol and blood glucose in the elderly. In an embodiment, thesoluble to insoluble ratio of the composition is approximately 4:1 to1:4. In a preferred embodiment, the soluble to insoluble fiber ratio isapproximately 1:3.

In the soluble/insoluble mixture, soluble fiber provides gut fuel byproviding short chain free fatty acids in the large intestine.Additionally, the inventors believe that soluble fiber retains moisture.As a result thereof, while the total amount of fiber provided by thecomposition of the present invention is less than other standardproducts, the amount of soluble fiber provided is higher.

The lipid source of the present invention includes a mixture of mediumchain triglycerides (MCT) and long chain triglycerides (LCT). The lipidsource of the present invention is approximately 26% to about 36% of thecaloric content of the composition. In an embodiment, the lipid sourceis approximately 30% of the caloric content of the composition.

The lipid source includes at least 20% from medium chain triglycerides.Such medium chain triglycerides are easily absorbed and metabolized inthe elderly patient's body. The remainder of the lipid source is amixture of long chain triglycerides. Suitable sources of long chaintriglycerides are canola oil, corn oil, soy lecithin and residual milkfat. The lipid profile containing such long chain triglycerides isdesigned to have a polyunsaturated fatty acid omega-6 (n-6) to omega-3(n-3) ratio of approximately 4:1 to 10:1. The proposed ratio of n-6:n-3is designed to prevent suppression of the immune system caused byexcessive n-6 fatty acids.

In an embodiment, the composition of the present invention includes asource of beta-carotene. Beta-carotene meets a portion of the requiredvitamin A, thereby meeting micronutrient requirements in a small caloricvolume. It is also an important nutrient with anti-oxidant properties.For example, it may reduce or mitigate symptoms of heart disease inaging adults. Adequate amounts of beta-carotene may also protect againstcataracts. The composition preferably includes approximately 2 to 10mg/L of beta-carotene. In an embodiment, beta-carotene is present in anamount of approximately 6 mg/L.

Still further, the present invention, in an embodiment, includes aspecialized vitamin and mineral profile. The composition includes atleast 100% of the USRDA of all vitamins and minerals. Moreover, thecomposition includes higher levels of the key vitamins and mineralsfound to be deficient in the institutionalized elderly. Vitamin-mineraldeficiencies are often associated with protein-energy malnutrition inthe elderly. The increased levels of vitamins and minerals exceed U.S.RDA (for normal, healthy adults) to meet the enhanced needs of thegeriatric adults. As a result, utilizing the composition of the presentinvention eliminates the need for vitamin and mineral supplementation.

Specifically, the composition of the present invention preferablyincludes increased levels of vitamin C, zinc, vitamin D, vitamin E,vitamin A, folic acid, vitamin B₆, vitamin B₁₂, thiamine, riboflavin,calcium, and selenium.

Vitamin C is preferably present in an amount of approximately 120 to 300mg/L. Blood levels of vitamin C tend to decline with age. In fact,greater than 40% of elderly may take in less than half of the U.S. RDAfor vitamin C. Even mild deficiencies may play a role in thepathogenesis of declining neurocognitive function in aging adults.Increased doses may be associated with increased immune function andexert a protective effect against cancer, heart disease and cataracts.In an embodiment, vitamin C is present in an amount of approximately 240mg/L.

Zinc is necessary to maintain skin integrity, rate of epithelializationand collagen strength. Since intake and intestinal absorption decreasewith age, low serum levels have been documented in the elderly.Supplementation with adequate zinc has been shown to restore immunefunction. The composition of the present invention includes fromapproximately 15 to 50 mg/L of zinc. In an embodiment, zinc is presentin an amount of approximately 24 mg/L.

Vitamin D is necessary for adequate phosphorous absorption. Likewise,calcium absorption is impaired in the elderly and higher levels ofvitamin D help with absorption and decrease hyperthyroidism. Stillfurther, a deficiency of vitamin D caused by lack of sun exposure may becommon in the institutionalized elderly. Moreover, current RDA of thevitamin may be too low for the elderly to maintain serum parathyroidhormone concentrations and healthy bone mass. The composition of thepresent invention includes from approximately 400 to 800 IU/L of vitaminD. In an embodiment, vitamin D is present in approximately 600 IU/L.

Vitamin E acts as an antioxidant and may protect against age-relatedaccumulation of free-radical reactions and greater lipid peroxidationthat may contribute to degeneration and disease. Supplementation withvitamin E has been shown to enhance cell-mediated immunity in theelderly. The composition of the present invention includes fromapproximately 60 to 180 IU/L of vitamin E. In an embodiment, vitamin Eis present in an amount of approximately 100 IU/L.

The amount of vitamin A, also an antioxidant, is increased as comparedwith other similar formulas, Vitamin A acts as a free radical scavengerand is present in the composition in approximately 3000 to 6000 IU/L. Inan embodiment, vitamin A is present in approximately 4000 IU/L.

Vitamin B₆ and folic acid are at increased levels because vitamin B₆ andfolic acid absorption in the elderly is inefficient. Also, there is ahigh degree of deficiency of these in the elderly population. In fact,vitamin B₆ deficiency has been associated with neurological changes andimmunocompetence in the elderly. The composition of the presentinvention includes from approximately 2 to 8 mg/L of vitamin B₆ andapproximately 400 to 1600 μg/L of folic acid. In an embodiment, vitaminB₆ and folic acid are present in amounts of approximately 4 mg/L and1200 μg/L, respectively.

Vitamin B₁₂ is at an increased level in the composition due todeficiencies in the elderly from atrophic gastritis and impairedabsorption. Serum B₁₂ is known to decline with age. The composition ofthe present invention includes from approximately 6 to 18 μg/L ofvitamin B₁₂. In an embodiment, vitamin B₁₂ is present in an amount ofapproximately 12 μg/L.

Thiamine (B₁) transmits impulses for central and peripheral nerve cellfunction. Decreased intake of thiamine may be associated withneuromuscular malfunctions and heart failure. The composition of thepresent invention includes from approximately 1.5 to 3 mg/L of thiamine.In an embodiment, thiamine is present in an amount of approximately 2.25mg/L.

Adequate amounts of riboflavin (B₂), the level of which is alsoincreased in the composition of the present invention, are required forproper energy and protein utilization. Deficiency of riboflavin mayresult in skin breakdown. The composition of the present inventionincludes from approximately 1.7 to 3.5 mg/L of riboflavin. In anembodiment, riboflavin is present in an amount of approximately 2.55mg/L.

As stated above, calcium absorption is impaired in the elderly. Thus,increased levels of calcium are included in the composition of thepresent invention. Calcium is required for tissue repair. Moreover,calcium is important in slowing/preventing bone loss in postmenopausalosteoporosis. Increased intake may be required for adequate calciumbalance. The composition of the present invention includes fromapproximately 800 to 1600 mg/L of calcium. In an embodiment, calcium ispresent in an amount of approximately 1250 mg/L.

Still further, selenium is at an increased level in the composition ofthe present invention. Selenium acts as an anti-oxidant and an immunestimulant. It also has some anti-inflammatory action. The composition ofthe present invention includes from approximately 50 to 150 mg/L ofselenium. In an embodiment, selenium is present in an amount ofapproximately 80 μg/L.

The composition of the present invention is a ready-to-use enteralformulation. The composition can be used as a supplement or for totalenteral nutritional support. The composition can be tube-fed to apatient, or fed by having the patient drink same. Preferably, thecaloric density of the composition is 1.2 kcal/ml and yields anon-protein calorie-to-nitrogen ratio of 114:1 to promote positivenitrogen balance.

By way of example, and not limitation, an example of a suitablecomposition that may be used pursuant to the present invention is asfollows:

The composition includes the following ingredients: protein: caseinate;carbohydrate: maltodextrin; fat: canola oil, corn oil, soy lecithin, andresidue milk fat; dietary fiber; water; vitamin A; beta-carotene;vitamin D; vitamin E; vitamin K; vitamin C; thiamine (B₁); riboflavin(B₂); niacin; vitamin B₆ ; folic acid; pantoth. acid; vitamin B₁₂ ;biotin; choline; taurine; carnitine; calcium; phosphorus; magnesium;zinc; iron; copper; manganese; iodine; sodium; potassium; chloride;chromium; molybdenum; and selenium.

The composition of the present invention has the following nutrientcomposition (per 1200 calories):

    ______________________________________                                        Nutrient Composition                                                                        Amount        % U.S. RDA*                                       ______________________________________                                        Protein       54       g        120                                           Carbohydrate  156      g        **                                            Fat***        40.6     g        **                                            Dietary Fiber 10                **                                            Water         742      ml       **                                            Vitamin A     4000     IU       280****                                       Beta-Carotene 6        mg       **                                            Vitamin D     600      IU       150                                           Vitamin E     100      IU       333                                           Vitamin K     80       mcg      **                                            Vitamin C     240      mg       400                                           Thiamine (B.sub.1)                                                                          2.25     mg       150                                           Riboflavin (B.sub.2)                                                                        2.55     mg       150                                           Niacin        40       mg       200                                           Vitamin B.sub.6                                                                             4        mg       200                                           Folic Acid    1200     mcg      300                                           Pantoth. Acid 15       mg       150                                           Vitamin B.sub.12                                                                            12       mcg      200                                           Biotin        400      mcg      133                                           Choline       452      mg       **                                            Taurine       100      mg       **                                            Carnitine     100      mg       **                                            Calcium       1250     mg       125                                           Phosphorus    1000     mg       100                                           Magnesium     400      mg       100                                           Zinc          24       mg       160                                           Iron          18       mg       100                                           Copper        2        mg       100                                           Magnesium     4        mg       **                                            Iodine        150      mcg      100                                           Sodium        763      mg       **                                            Potassium     1560     mg       **                                            Chloride      1296     mg       **                                            Chromium      100      mcg      **                                            Molybdenum    150      mcg      **                                            Selenium      80       mcg      **                                            ______________________________________                                         *U.S. Recommended Daily Allowance for Adults and Children 4 or More Years     of Age                                                                        **U.S. RDA Not Established.                                                   ***MCT Provides 8.12 Grams                                                    ****Vitamin A Calculated As a Combination of Retinol (80% of U.S. RDA per     1000 ml) Plus BetaCarotene. Conversion of BetaCarotene to Retinol Occurs      in the Body Up to a Maximum of 10,000 IU per 100 ml (200% of U.S. RDA).  

It will be understood that various modifications to the presentlypreferred embodiments described herein will be apparent to those skilledin the art. Such changes and modifications can be made without departingfrom the spirit and scope of the present invention and withoutdiminishing its attendant advantages. It is therefore intended that suchchanges and modifications be covered by the appended claims.

We claim:
 1. A method for providing nutrition to an elderly patientcomprising enterally administering to the patient an effective amount ofa composition comprising:a protein source including at least 18% of thecalorie distribution of the composition; a carbohydrate source; a lipidsource including a mixture of medium and long chain triglycerides; and adietary fiber source including soluble and insoluble fiber.
 2. Themethod of claim 1 wherein the composition provides at least 100% of theUSRDA of vitamins and minerals in approximately 1200 calories.
 3. Themethod of claim 1 wherein the long chain triglycerides are selected toprovide a ratio of n-6 to n-3 fatty acids of about 4:1 to about 0:1. 4.The method of claim 1 wherein the composition includes a source ofbeta-carotene.
 5. The method of claim 1 wherein the composition includesthe following vitamins and minerals:Vitamins 120 to 300 mg/L Zinc 15 to30 mg/L Vitamin D 400 to 800 mg/L Vitamin E 60 to 180 mg/L Vitamin A3000 to 6000 IU/L Folic Acid 400 to 1600 μg/L Vitamin B₆ 2 to 8 mg/LVitamin B₁₂ 6 to 18 μg/L Thiamine 1.5 to 3 mg/L Riboflavin 1.7 to 3.5mg/L Calcium 800 to 1600 mg/L Selenium 50 to 150 mg/L.
 6. The method ofclaim 1 wherein the composition has a caloric density of approximately1.2 kcal/ml.
 7. A method for providing nutrition to an elderly patientcomprising enterally administering to the patient an effective amount ofa composition comprising:a protein source including at least 18% of thecalorie distribution; a carbohydrate source including a source ofdietary fiber including soluble fiber and insoluble fiber; and a lipidsource including a mixture of medium and long chain triglycerideswherein the long chain triglycerides are selected to provide a ratio ofn-6 to n-3 fatty acids of about 4:1 to about 10:1.
 8. The method ofclaim 7, wherein the protein source comprises at least 18% of thecalorie distribution of the composition.
 9. The method of claim 7wherein the composition provides at least 100% of the USRDA of vitaminsand minerals in approximately 1200 calories.
 10. The method of claim 7wherein the composition includes a source of beta-carotene.
 11. Themethod of claim 7 wherein the composition includes the followingvitamins and minerals:Vitamin C 120 to 300 mg/L Zinc 15 to 30 mg/LVitamin D 400 to 800 mg/L Vitamin E 60 to 180 mg/L Vitamin A 3000 to6000 IU/L Folic Acid 400 to 1600 μg/L Vitamin B₆ 2 to 8 mg/L Vitamin B₁₂6 to 18 μg/L Thiamine 1.5 to 3 mg/L Riboflavin 1.7 to 3.5 mg/L Calcium800 to 1600 mg/L Selenium 50 to 150 mg/L.
 12. The method of claim 7wherein the composition has a caloric density of approximately 1.2kcal/ml.
 13. A method for providing nutrition to an elderly patientcomprising enterally administering to the patient an effective amount ofa composition comprising:a protein source comprising at least 18% ofcalorie distribution; a carbohydrate source including a source ofdietary fiber including soluble and insoluble fiber; a lipid sourceincluding a mixture of medium and long chain triglycerides; a vitaminand mineral source including the following vitamins and minerals intheir respective amounts: Vitamin C 120 to 300 mg/L Zinc 15 to 30 mg/LVitamin D 400 to 800 mg/L Vitamin E 60 to 180 mg/L Vitamin A 3000 to6000 IU/L Folic Acid 400 to 1600 μg/L Vitamin B₆ 2 to 8 mg/L Vitamin B₁₂6 to 18 μg/L Thiamine 1.5 to 3 mg/L Riboflavin 1.7 to 3.5 mg/L Calcium800 to 1600 mg/L Selenium 50 to 150 mg/L.
 14. The method of claim 13wherein the long chain triglycerides are selected to provide a ratio ofn-6 to n-3 fatty acids of about 4:1 to about 10:1.
 15. The method ofclaim 13 wherein the composition has a caloric density of approximately1.2 kcal/mL.
 16. The method of claim 13 wherein the composition includesat least 100% of USRDA of vitamins and minerals in approximately 1200calories.